Item


Efficacy of intravenous paracetamol compared to placebo in the prevention of patent ductus arteriosus in very preterm newborns

PDA. OBJECTIVE : The purpose of the present study is to determine the efficacy of paracetamol in the prevention of PDA in comparison to placebo in very preterm newborns. Safety of paracetamol will also be assessed. DESIGN AND SETTING : A triple-blinded randomized trial will be performed among the Neonatal Intensive Care Units (NICUs) of Hospital universitari Dr. Josep Trueta in Girona and Hospital universitari Vall d’Hebron in Barcelona. PARTICIPANTS, INTERVENTION AND METHOD: A total of 336 prematures under 32 weeks of gestation will be randomized into one of the two treatment groups. One group will be receiving paracetamol (loading dose of 20 mg/kg followed by a maintenance dose of 7.5 mg/kg/6h) while the other group will receive placebo. Follow-up echocardiographies will be held on day three and seven after beginning of treatment, as well as on month one and three, to asses the presence or not of PDA, which will be the main outcome. Physical exploration, blood analysis and transfontanellar echographies will be held regularly to evaluate drug adverse effects and comorbidities, to assess secondary outcomes

Manager: Mayol Canals, Lluis
Other contributions: Universitat de Girona. Facultat de Medicina
Author: Horta Puig, Anna Maria
Date: 2017 November
Abstract: PDA. OBJECTIVE : The purpose of the present study is to determine the efficacy of paracetamol in the prevention of PDA in comparison to placebo in very preterm newborns. Safety of paracetamol will also be assessed. DESIGN AND SETTING : A triple-blinded randomized trial will be performed among the Neonatal Intensive Care Units (NICUs) of Hospital universitari Dr. Josep Trueta in Girona and Hospital universitari Vall d’Hebron in Barcelona. PARTICIPANTS, INTERVENTION AND METHOD: A total of 336 prematures under 32 weeks of gestation will be randomized into one of the two treatment groups. One group will be receiving paracetamol (loading dose of 20 mg/kg followed by a maintenance dose of 7.5 mg/kg/6h) while the other group will receive placebo. Follow-up echocardiographies will be held on day three and seven after beginning of treatment, as well as on month one and three, to asses the presence or not of PDA, which will be the main outcome. Physical exploration, blood analysis and transfontanellar echographies will be held regularly to evaluate drug adverse effects and comorbidities, to assess secondary outcomes
Format: application/pdf
Document access: http://hdl.handle.net/10256/15666
Language: eng
Collection: Medicina (TFG)
Rights: Attribution-NonCommercial-NoDerivatives 4.0 International
Rights URI: http://creativecommons.org/licenses/by-nc-nd/4.0/
Subject: Infants prematurs -- Malalties
Premature babies -- Diseases
Cardiopatia congènita en els infants
Congenital heart disease in children
Paracetamol -- Eficàcia
Paracetamol -- Effectiveness
Persistència del conducte arteriós
Patent ductus arteriosus
Title: Efficacy of intravenous paracetamol compared to placebo in the prevention of patent ductus arteriosus in very preterm newborns
Type: info:eu-repo/semantics/bachelorThesis
Repository: DUGiDocs

Subjects

Authors


Warning: Unknown: write failed: No space left on device (28) in Unknown on line 0

Warning: Unknown: Failed to write session data (files). Please verify that the current setting of session.save_path is correct (/var/lib/php5) in Unknown on line 0